FDA new published documents

July 28, 2016

eCTD and electronic submission will become mandatory on short future

See you at… CPHI, Biospain and TOPRA

July 25, 2016

After the holidays we have 3 important appointments, in which we can meet?

Asphanews June!

July 12, 2016

Keep up on the latest news, don’t miss it!

Do you want to know more about ISO IDMP implementation?

June 30, 2016

“Jornada sobre la implementación del IDMP (Identification of Medicinal Products) y manejo de Datos” on 5th July in Madrid

eCTD New EU Module 1 Specification

June 28, 2016

A new version of the EU eCTD Module 1 Specification (3.0.1) which can be used from 1st July 2015 and must be used from 1st October 2016.

eCTD will become mandatory for ASMF/DMF

June 22, 2016

From January 2017 EDQM will require eCTD submissions for new applications for CEPs

Upcoming new THAI eCTD and Module 1

June 21, 2016

Did you know that Food and Drug Agency of Thailand is releasing new TH Module 1 with TH regional schema V1.0. eCTD submission?

Asphalion organized the 2nd Scientific Advice meeting of iHIVARNA project

June 9, 2016

The meeting was arranged in order to ask AEMPS some guidance in order to prepare the coming submission of the phase IIa clinical trial inside the iHIVARNA project.

36th AEFI Symposium

June 7, 2016

Our team is attending now the inaugural conference.

The MYOCURE project website is now available

May 30, 2016

New therapies for rare diseases: New EU project MYOCURE advances treatment of rare hereditary muscle disorders.

Complimentary Webinar: Pharmacovigilance Inspection Readiness in Spain: Electronic Safety Database

May 17, 2016

EXTEDO and ASPHALION invite you to their webinar “Pharmacovigilance Inspection Readiness in Spain: Electronic Safety Database” on 23 May 2016.

Asphalion is happy to annouce that is a proud member of CataloniaBio.

May 10, 2016

CataloniaBio is the association of companies in the health and life sciences arena in Catalonia.

Free Webinar!

April 18, 2016

The implementation and use of the electronic Aplication Form (eAF) and the RAEFAR electronic platform – 25th April at 10:00h GMT

Did you know that…?

April 18, 2016

Last news and services from Asphalion.

Thanks for visiting us!

April 14, 2016

Our team attended the 28th Annual DIA Euromeeting on 6-8 April. After three days of presentations and meetings with clients, the results have been more than satisfactory.

Asphalion will be participating at Informa’s Regulatory Information Management event

April 13, 2016

Asphalion is delighted to offer an exclusive 25% discount to its clients, click here to get it!

Happy World Health Day!

April 7, 2016

Asphalion contributes in the development of a new therapy to treat Diabetes in a project called ELASTISLET

Meet us at DIA!

March 17, 2016

ASPHALION will be present at booth K11 of DIA’s 28th Annual EuroMeeting in Hamburg next April.

Health Canada approves Asphalion for electronic submission preparation and submission by Gateway

March 15, 2016

Asphalion is happy to announce that it has been certified by Health Canada to perform electronic submission by the Gateway.

New version of QRD templates available

February 18, 2016

EMA has just published a new version of QRD templates for product information (version 10 for CP and version 4 for MRP/DCP)

Asphalion organizes the iHIVARNA Project’s 5th General Assembly Meeting

February 17, 2016

The first results with the first vaccinated patients are quite optimistic and the discussion on the phase II clinical trial was productive, setting the foundations for this second part of the project.

Second photo contest of Asphalion’s employees

February 16, 2016

We hope you enjoy them as much as we do!

Working in Centralised Procedures?

February 16, 2016

EMA is requesting Marketing Authorisation Holders and Drug Substance manufacturers (ASMF Holders) to use the full life cycle possibilities of eCTD.

EudraCT the new version is now fully operational

February 2, 2016

EMA is now proposing a tight timeline of 6 months in which clinical trial results have to be entered into the system.

OPEN SEMINAR 2016: FDA Road to Success

January 7, 2016

Your seminar to become an expert in FDA Regulatory Affairs and eSubmission! Save the date! 9-10th March’16, Munich (Germany)

Latest news from eAF

December 22, 2015

The use of the electronic Application Form (eAF) is going to be mandatory.

PRIME Scheme

December 22, 2015

As part of the European Medicines Agency strategy to reinforce regulatory support and improve timely access to medicines, a new scheme will be launched in Q1 2016 to further support development of new medicines addressing major public health needs.

Changes with the report to the art 57 database

December 21, 2015

The EMA management board has released a communication that from 1 February 2016

Asphalion is looking for partners like you!

December 17, 2015

If you have a project that falls under the eligibility criteria for Horizon 2020 Programme, Asphalion is available to provide you with our regulatory expertise.

Asphalion contributes in recovery Nepal after the earthquake of April 15

December 16, 2015

We are very pleased to have participated in this charity project where the main objective has been to help recover Nepal after the earthquake in April 2015.

Latest news from the ISO IDMP S(ubstance)&P(roduct) meeting at EMA

December 4, 2015

The phased wise implementation of ISO IDMP will probably mean first submission of data end 2017 or 2018.
However, this is depending on the finalisation of the ISO standards

AEMPS establishes recommendation for the implementation of safety devices in medicinal products

October 25, 2015

It will be applicable as of February 9, 2019